The inability of a person to control the flow of urine results from a number of different medical conditions, particularly conditions associated with advanced age. Also, in certain cases a patient for medical treatment may not necessarily be incontinent but may be immobile or may otherwise be unable to relieve himself normally. In these situations it is desirable to provide some means of urine collection.
A number of external catheter systems have been devised for urine drainage for incontinent males. U.S. Pat. No. 4,589,874 to Riedel et al. shows an external catheter in combination with an applicator collar. The catheter includes a thin sheath with an adhesive applied to at least a portion of its inside wall. The sheath is adapted to fit snugly over the patient's penis so that the adhesive coating attaches it directly to the skin of the penile shaft.
A sealant pad for an external catheter is shown in U.S. Pat. No. 4,534,768 to Osburn et al. The sealant pad disclosed by Osburn et al. forms an annular band with an adhesive coating on both its inner and outer surfaces. This sealant pad or band is attached, via the adhesive on its inner surface, to the patients' penis just behind the glans. An external catheter sheath is placed over this pad or band, the outer surface of the band adhering to the catheter sheath so that the band provides a seal between the penis skin and the catheter sheath inside wall. As in the Riedel et al. patent, the catheter sheath shown by Osburn et al. attaches directly to the skin of the penile shaft.
U.S. Pat. No. 4,588,397 to Giacalone also shows an external catheter for males. The Giacalone system includes a pair of specially adapted briefs with an external catheter mounting and sealing collar. The briefs are won by the patent so that the patient's penis extends through an opening in the collar. The catheter sheath fits loosely around the patient's penis and attaches at its proximal end to the collar, which includes a sealing arrangement that contacts the skin toward the base of the penile shaft to form a seal. Although the catheter sheath in the Giacalone system does not contact the penis directly to form a seal, the collar to which the catheter sheath is attached includes a sealing member that contacts the penile shaft to form a seal.
There were a number of problems associated with the prior external catheter systems. In system where the catheter was attached to the skin of the penile shaft, either directly by an adhesive coating as shown by Riedel et al., or indirectly through an adhesive band as shown by Osburn et al., the fit between the penis and the catheter sheath material had to be tight at all times in order to prevent leakage. Furthermore, the fit had to be tight to prevent the catheter sheath from coming off during large flows of urine.
However, if the fit between the penis and the catheter sheath was too tight, the sheath often caused pain or discomfort to the patient generally, and also caused edema, inflammation, and chafing. The problem was exacerbated during involuntary erections. Furthermore, adhesive coated external catheter sheaths were difficult to apply.
Problems also arose with the external catheter system shown by Giacolone. The Giacolone system also obtained a seal against the penile shaft, not with the catheter sheath itself, but with a collar to which the catheter sheath was attached. The collar had to fit tightly to prevent leakage, but if it was too tight, it caused discomfort generally and particularly during involuntary erections. Furthermore, the briefs had to be positioned carefully on the patient and therefore restricted the patient's movement. The briefs were also expensive to produce and greatly increased the cost of the system.
None of the prior external catheters provided a secure, yet comfortable seal and manner of attachment.
It is, therefore, an object of the invention to provide for male patients an external catheter urine collection system that is comfortable to the patient and provides an effective seal to prevent leakage.
Another object of the invention is to provide an external catheter that provides a seal that does not contact the patient's glans or penile shaft.
Another object of the invention is to provide an external catheter that does not restrict the patient's movement.
A further object of the invention is to provide an external catheter that is lightweight and inexpensive to manufacture.